"Hemodialysis fistula stenosis" "Vessel narrowing in fistula of dialysis patiënten"
Conditions
Interventions
PTA of the vein of the hemodialysis fistula using a placlitaxel coated balloon
or a conventional balloon.
Sponsors
Albert Schweitzer Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Hemodialysis patients presenting more than once a year with repetitive severe stenoses of the draining vein of the fistula, evaluated with duplex ultrasound and reconfirmed at angiography. Patients with a life expectancy of at least one year will be included.
Exclusion criteria
Exclusion criteria: Refusal or no motivation to participate in the study or receive PTA treatment. Pregnancy or planing to become pregnant during the study. Known allergic reactions in the past with regard to iodinated contrast agents, paclitaxel, heparine or aspirine. Under 18 years of age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are 12-months patency of the use of placlitaxel coated balloons and conventional balloons. Endpoints being re-intervention, more than 50% stenosis of the treated segment of the hemodialysis fistula, occlusion of the fistula at duplex ultrasound and blood flow below 600 ml/min. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are initial angiographic success (less than 30% stenosis), peri-procedural complications (within 24 hrs) and late complications (within 30 days). Further secundairy endpoint are time to hemostasis of the puncture site and diameter of hematoma arond the puncture site. Complications include balloon rupture, vessel disruption, significant bleeding, hypotension, allergic reaction, infection, pulmonary embolus, hand ischemia, occlusion and thrombosis of the fistula, immediate surgical intervention and death. Also evaluation with duplex US at 2 weeks, 3, 6, and 24 months will be taken into accopunt as secondary study outcome. | — |
Countries
Netherlands
Outcome results
None listed